Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

NCT07173959 | Not Yet Recruiting DMC

• 1 other identifier: K8156
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Previously, there was a lack of relevant research on digital therapeutics for the systematic management of gestational diabetes in China. A data-driven digital therapy product for gestational diabetes (doctor's end + patient's end) was established. This product integrates functions such as information recording, risk assessment, evaluation and suggestion, prescription issuance, and knowledge popularization. It aims to provide personalized blood glucose regulation plans for pregnant women with gestational diabetes and enhance the health awareness and self-management ability of families with gestational diabetes.

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

• The rate of achieving blood glucose targets

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (2)

• Weight gain during pregnancy

  From enrollment to the end of treatment at 16 weeks

• The incidence of adverse pregnancy outcomes

  During childbirth

Study Arms (2)

intervention group

EXPERIMENTAL

This group of pregnant women received nutritional intervention and feedback provided by a digital therapy product (mini-program) relying on an AI system on the basis of routine obstetric care

Device: GDM digital Therapy mini-program

control group

PLACEBO COMPARATOR

Pregnant women randomly assigned to the control group used a mini-program that looked the same as digital therapy products but only had educational and recording functions on the basis of routine obstetric care

Device: Pregnancy record and education mini-program

Interventions

GDM digital Therapy mini-program DEVICE

The main functions of digital therapy products include personalized recipe recommendations, exercise and diet records and personalized analysis, blood sugar and weight monitoring, and the generation of weekly and monthly electronic comprehensive reports. The content of the electronic comprehensive reports includes the weight gain, blood sugar status, examination indicators, mood, and the proportion of diet and exercise of pregnant women in line with the system's recommendations during this period of time.

intervention group

Pregnancy record and education mini-program DEVICE

This mini-program looks the same as digital therapy products but only has the functions of education and record-keeping

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 28 weeks of pregnancy GDM was diagnosed by OGTT test single pregnancy Be able to use smart phone APP to conduct intervention management based on digital therapy software program

You may not qualify if:

• Suffering from type 1 or type 2 diabetes Other serious organic diseases With severe mental disorders Intervention management cannot be carried out as planned using digital therapeutics

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Liangkun Ma

CONTACT

+8613021961166; maliangkun@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share